Delivery Device Continues To Be Intarcia’s Downfall Ahead Of FDA Panel On Nonapproval of Implantable GLP-1

 
• By Sarah Karlin-Smith

CDER reviewers don’t buy that safety concerns with exenatide implant ITCA 650 are in line with the risks labeled for already approved GLP-1 agonists for type 2 diabetes – even other formulations of the same drug – potentially due to unique considerations associated with Intarcia’s delivery method.

delivery driver on scooter
Mode of delivery was meant to be a selling point but instead is one of Intarcia’s ITCA 650’s biggest challenges to FDA approval • Source: Shutterstock

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